ZIDOVUDINE - Generic Drug Details

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What are the generic sources for zidovudine and what is the scope of patent protection?

Zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, and Ranbaxy Labs Ltd, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for zidovudine. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ZIDOVUDINE

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	19
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	524
Patent Applications:	5,461
Drug Prices:	Drug price trends for ZIDOVUDINE
What excipients (inactive ingredients) are in ZIDOVUDINE?	ZIDOVUDINE excipients list
DailyMed Link:	ZIDOVUDINE at DailyMed

See drug prices for ZIDOVUDINE

Recent Clinical Trials for ZIDOVUDINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Michelle Abou-Jaoude	Phase 1
Inflammasome Therapeutics	Phase 1
Johns Hopkins University	Phase 1/Phase 2

See all ZIDOVUDINE clinical trials

Generic filers with tentative approvals for ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ZIDOVUDINE

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for ZIDOVUDINE

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ZIDOVUDINE

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ZIDOVUDINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	ZIDOVUDINE	zidovudine	TABLET;ORAL	076844-001	Sep 19, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	ZIDOVUDINE	zidovudine	TABLET;ORAL	200732-001	Feb 23, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	ZIDOVUDINE	zidovudine	TABLET;ORAL	090092-001	Apr 25, 2008	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ZIDOVUDINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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